Giorn. It. Ost. Gin. Vol. XXVII - n. 7-8 Luglio-Agosto 2005
Sophy project: evidences intimate hygiene
A.R. GENAZZANI, B. PRATOIntroduction
Vaginal ecosystem is apparently an isolated and protected structure. The balance of this system is easily altered by anatomic contiguity with rectum and bladder, hormonal profile, pregnancy, traumas, sexual intercourse, and pharmacological therapies.
The importance of intimate hygiene, pH and vagi-nal flora in keeping the vagivagi-nal ecosystem in good balance is known and widely described. pH is a good
marker of the healthy condition of vaginal ecosystem and allows to early detect borderline situations for appropriate actions.
No systematic, nation-wide, current study is up to now available, on the correlation between vaginal pH and intimate hygiene in the different ages and condi-tion of the woman, mainly considering the modified hygienic and life style habits.
A project aimed to collect systematically data rela-ted to intimate hygiene with the target to build a large and representative sample of the woman population in the different ages and/or physiological conditions, has been realised.
A scientific board was settled to agree on protocol and case report form and involved Genazzani A. R. Gynaecology and Obstetrics University Dept., Univer-sity of Pisa; Bruni V. Obstetrics and Gynaecology In-stitute Pol. Careggi, Firenze; Di Nicola C. Physicians SUMMARY: Sophy project: evidences intimate hygiene.
A.R. GENAZZANI, B. PRATO
The importance of intimate hygiene, pH and vaginal flora in keeping the vaginal ecosystem in good balance is known and widely described.
No systematic, nation-wide, current study is up to now available, on the correlation between vaginal pH and intimate hygiene in the different ages and condition of the woman, mainly considering the modified hygienic and clothing habits.
A project aimed to collect systematically data related to intimate hygiene, in a representative sample of the Italian gynaecological population has been realised, helped by a specific website to insert the data.
Lifestyle, vaginal pH, intimate hygiene compliance, presence of symp-toms, gynaecological treatment stratified in different subgroups (prepubertal, fertile, pregnant, lactating, pre-menopause and menopause) have been recorded up to now on 119t women.
The Study on pH and Hygiene (SOPHY) provides a strong educational impact, pushing doctors and women in considering pH and intimate hygiene an important moment of their professional and daily life.
Each natural plant extract used in intimate hygiene (Sage, Thyme and Chamomile) confirmed its clinical activity on protecting against bacteria, mycoses and inflammation.
RIASSUNTO: Progetto Sophy
A.R. GENAZZANI, B. PRATO
L’importanza di igiene intima, pH e flora vaginale nel mantenere l’eco-sistema vaginale in buon equilibrio è nota e ampiamente descritta.
A tutt’oggi non sono disponibili studi sistematici, su scala nazionale, relative alla correlazione tra pH vaginale e igiene intima nelle differenti età e condizioni della donna, soprattutto in considerazione delle modificate abitudi-ni igieabitudi-niche e di abbigliamento.
È stato realizzato un progetto mirato a raccogliere sistematicamente dati correlati con l’igiene intima, in un campione rappresentativo della popolazione ginecologica italiana, con l’aiuto di uno specifico sito internet per inserire i dati.
Stile di vita, pH vaginale, igiene intima, presenza di sintomi, trattamen-to ginecologico stratificatrattamen-to in differenti sottrattamen-togruppi (prepubere, fertile, gravi-danza, allattamento, pre-menopausa e menopausa) sono stati registrati in 1197 donne.
Lo studio “Study on pH and Hygiene” (SOPHY) fornisce un forte impatto educazionale, spingendo medici e donne a considerare pH vaginale e igiene intima un importante momento della loro vita quotidiana e professiona-le.
Ciascun estratto naturale vegetale usato nell’igiene intima (Salvia, Thymus e Camomilla) ha confermato la sua attività clinica nella protezione contro batteri, micosi e infiammazione.
KEYWORDS: Intimate hygiene - Plant extracts - Vaginal pH - Bacterial vaginosis.
Igiene intima - Estratti vegetali - pH vaginale - Vaginosi batterica.
Ospedale Riuniti di Santa Chiara - Pisa Divisione di Ginecologia e Ostetricia
Dipartimento di Medicina della Procreazione e dell’Età Evolutiva Paper presented at the 12th World Congress on Human Reproduction, 10-13 March 2005, Venice, Italy
Women Association, Roma; Cianci A. Gynaecology University Dept, Ospedale Santo Bambino, Catania; Graziottin A. Medical and Gynaecological Sexology, Osp. S. Raffaele Resnati, Milano; Guaschino S. Clinica Obstetrics and Gynaecology University Dept., Trieste; Nicoletti G. Microbiology and Gynaecological Sciences Dept., University of Catania; Novellino E. Pharmaceutical Chemistry, Pharmacy, University of Napoli; Schito G.C. Microbiology Istituto, University of Genova; Sismondi P. Oncological Gynaecology Chair, Ospedale Mauriziano, Torino.
Aim of the study is also to evaluate the impact of intimate hygiene carried out with specific natural plant extracts on the vaginal ecosystem balance. In fact, natural plant extracts, namely the ones derived by Salvia officinalis, Thymus vulgaris, and Chamomila matricaria, are endowed with pharmacological and microbiological activities, linked to their active princi-ples corresponding to salviol and pinene (1-13), thymol and carvacrol (1, 2, 14-30) and bisabolol (1, 2, 12, 31).
Material and methods
More than one thousand of Italian gynaecologists are participating to the standardised protocol, filling appropriate case report forms, with the help of a spe-cific website to insert the data. Each investigator
receives individual login and password to have a pro-tected access to the website.
Selection criteria. The investigators collect the data
on 12 consecutive women referring to the doctor’s observation, 2 for each of the following physiological conditions: 2 adolescents (from menarche+following 6 yrs), 2 fertile, 2 pregnant, 2 lactating, 2 pre-meno-pause, 2 menopause.
To achieve an unbiased interpretation of the data, the sample has not be “chosen”, but collected fol-lowing the random order of the woman referring to the doctor’s observation.
Evaluation criteria. The investigator fills the CRF
inserting data on history, lifestyle and diet, vaginal pH (a standard set for pH determination is given to each doctor), presence of signs/symptoms at start, or the ones appeared during the treatment, stratified in dif-ferent subgroups - adolescents, fertile, pregnant, lac-tating, pre-menopause and menopause - possible dia-gnosis of bacterial vaginosis, current pharmacological therapies.
Treatments. The investigator, beside the possible
pharmacological prescription required by the current clinical conditions, recommends the woman the most appropriate product for a correct intimate hygiene, according to the following scheme: Sage extract detergent for adolescents, fertile and pre-menopause, Fig. 2 - Signs and symptoms in Bacterial vaginosis before and after 4 weeks of Thyme extract daily use for intimate hygiene (b = before, a = after; * p < 0.05; *** p < 0.0001 vs baseline at χχ2 2x4 test).
Thyme extract detergent for pregnancy and lactation, Chamomile extract detergent for menopause.
Moreover, independently from the physiological condition, Thyme extract detergent is recommended
for intimate hygiene in presence of suspected or ascertained bacterial vaginosis, mycosis or attendance of environments at risk and Chamomile extract deter-gent is advised for itching and vulvar burning due to hyperacidity
Each detergent is used 1 or 2 times/day for 4 weeks.
Statistical analysis. Chi square test and Student’s t
test were applied when appropriate to calculate the statistical significance of the 4-week effect compared to baseline values.
Timing of the study. The observational study started
with the delivery of login and password. The study is currently running and the preliminary results are here presented.
Results
The characteristics of the 1197 women studied are reported in Table I. Body Mass Index (BMI) is positi-vely correlated with increasing age, as expected, bac-terial vaginosis is more frequent in fertile age and Candida in adolescents.
The frequent use of clothing at risk of vaginal infections was generally by far more linked to adole-scents and less in menopause. Intimate hygiene is reported more frequently in fertile age and is lower in menopaused women (Fig. 1).
TABELLAI - CHARACTERISTICS OF THE POPULATION STUDIED (MEAN ± SD)
Adolescents Fertile Pre-menopause Menopause Pregnancy Puerperium
n 109 360 126 228 225 149
Age (years) 17.3 ± 3.0 32.7 ± 7.9 47.8 ± 5.4 56.4 ± 10.5 30.7 ± 4.8 31.6 ± 6.1
BMI (kg/m2) 20.6 ± 2.9 22.3 ± 4.0 23.6 ± 3.4 25.6 ± 4.4 24.3 ± 4.4 24.2 ± 6.2
Bacterial Vaginosis (%) 14.7 19.2 18.3 11.8 12.9 16.1
Candida (%) 28.4 21.9 15.9 8.3 20.9 11.4
TABELLAII - PH BEFORE AND 4 WEEKS AFTER DAILY USE OF PLANT EXTRACTS (SAGE. THYMUS AND
CHAMOMI-LE) FOR INTIMATE HYGIENE IN DIFFERENT AGES AND PATHOPHYSIOLOGIC GROUPS: ADOLESCENT (A), FER-TILE (F), PRE-MENOPAUSE (PM), MENOPAUSE (M), PREGNANCY (P), PUERPERIUM (Pu), BACTERIAL VAGINOSI (BV) AND CANDIDA (C) (MEAN ± SD).
Sage Chamomile Thymus
% A F Pm M P Pu BV C 4.88 4.88 4.94 5.04 4.91 5.17 5.35 5.2 before ± 0.84 ± 0.76 ± 0.60 ± 0.85 ± 0.66 ± 0.8 ± 0.70 ± 0.89 4.48 4.59 4.58 4.96 4.62 4.60 4.61 4.57 after ± 0.55 ± 0.61 ± 0.50 ± 0.67 ± 0.55 ± 0.72 ± 0.79 ± 0.64 p t test < 0.01 < 0.01 < 0.01 NS < 0.01 < 0.01 < 0.01 < 0.01
Fig. 3 - Signs and symptoms in Candida infection before and after 4 weeks of Thyme extract daily use for intimate hygiene (b = before, a = after; * p < 0.05, ** p < 0.01, *** p < 0.0001, vs baseline at χχ22x4 test).
Contraceptive methods were more used in fertile age (52.8%) than in adolescents (42.2%) pre-meno-pause (32.5%) and puerperium (26.9), being oral contraceptive (OC) the preferred by adolescents and fertile women (30%) versus condom (C), and no difference between the two methods in pre-menopause (7.9% OC, 11.1%C) and puerperium (11.4% OC, 8.1% C). As concomitant treatment that could interact with the results, only less than 1% of local antimycotics in thyme treated group Fig. 4 - Signs and symptoms in Pregnancy before and after 4 weeks of Thyme extract daily use for intimate hygiene (b= before, a=after; * p < 0.05, ** p < 0.01, ***p < 0.0001, vs baseline at χχ22x4 test).
Fig. 7 - Microbiological evaluation in Bacterial vaginosis and Pregnancy before and after 4 weeks of Thyme extract daily use for intimate hygiene (b= before, a=after; * p < 0.05; ** p < 0.01 *** p < 0.0001 vs baseline at χχ22x3 test). Fig. 5 - Signs and symptoms in Puerperium before and after 4 weeks of Thyme extract daily use for intimate hygiene (b= before, a=after; ** p < 0.01, °°° p < 0.001, *** p < 0.0001, vs baseline at χχ22x4 test).
Fig. 6 - Signs and symptoms in Menopause before and after 4 weeks of Chamomile extract daily use for intimate hygiene (b= before, a=after; *** p < 0.0001 vs baseline χχ22x4test).
was reported.
Vaginal pH responded to the action of the diffe-rent plant extracts, showing that in all the stratified ages, but menopause, pH was statistically reduced after 4 weeks use of Sage extract in adolescents, ferti-le age and pre-menopause, and Thyme extract in bac-terial vaginosis, candida, pregnancy and puerperium (Tab. II).
Signs and symptoms in bacterial vaginosis, candi-da, pregnancy, puerperium and menopause were significantly reduced as severity and frequency (Figg. 2-6).
Microbiological evaluation showed a statistically significant normalisation in bacterial vaginosis, pre-gnancy, puerperium and in candida too, even if not significantly (Fig. 7). Leucorrhoea determined as quantity was significantly reduced in bacterial vagino-sis, candida, pregnancy and puerperium (Fig. 8).
The physician’s judgment on treatment and the overall conditions of the woman vs pre-treatment confirmed the positive results on the natural extract
daily use for intimate hygiene (Figg. 9-10).
Conclusions
The Study on pH and Hygiene (SOPHY) is provi-ding a strong educational impact. The study protocol, beyond the data on the activity of natural plant extracts in intimate hygiene, achieved the goal to push doctors and women in considering pH and intimate hygiene an important moment of their professional and daily life.
Each natural plant extract used (Sage, Thyme and Chamomile) confirmed clinically the experimental data of activity on bacteria, mycoses and inflammation.
As consequence of the antibacterial and antimyco-tic action expressed at vulvovaginal level by the active principles contained in Thyme and Sage extract, mean vaginal pH was reduced to normal values.
The positive physician’s judgment on treatment and favourable response of the overall conditions of the woman vs pre-treatment were in agreement with the results observed on signs and symptoms respecti-Fig. 8 - Leucorrhoea in Bacterial vaginosis, Candida, Pregnancy and Puerperium before and after 4 weeks of Thyme extract daily use for intimate hygiene (b= before, a=after; *** p < 0.0001; NS statistically not significant vs baseline at χχ22x3 test).
vely in Bacterial vaginosis, Candida, Pregnancy and Puerperium before and after 4 weeks of Thyme extract daily use and in menopause before and after 4 weeks of Chamomile extract daily use.
These data confirm the usefulness to practice intimate hygiene with appropriate active princi-ples aimed to protect against vulvovaginal infec-tions.
Acknowledgements
Thanks are given to the Scientific Board for the participation in the design of the study and the Sophy study group for the careful compliance to the proto-col.
microbial activity of essential oils and other plant extracts. J Applied
Microbiol 86: 985-990; 1999.
5. HO C.T., WANG M., WEI G.J., HUANG T.C., HUANG M.T.: Chemistry and antioxidative factors in rosemary and sage. Biofactors 13 (1-4): 161-166; 2000.
6. KAIJ-A-KAMB M., AMOROS M., GIRRE L.: Search of new
antiviral agents of plant origin. Pharm Acta Helv 67 (5-6):
130-147; 1992.
7. MEJLHOLM O., DALGAARD P.: Antimicrobial effect of
essen-tial oils on the seafood spoilage micro-organism Photobacterium phospho-reum in liquid media and fish products. Lett Appl Microbiol 34:
References
1. ANELLI R., BENVENUTI C., TORTORA L.: Sophy study
group, Clinical activity of plant extracts in intimate hygiene. 12thWorld
Cong Hum Reprod, 10-13 March, Venice, Italy, 2005. 2. BENVENUTI C., CAMANA M.G., MORTARA E.,
PORTALUPPI P., SETNIKAR I.: Natural compounds from
plant extract in gynaecology. 12thWorld Cong Hum Reprod,
10-13 March, Venice, Italy, 2005..
3. CHOI H.R., CHOI J.S., HAN Y.N., BAE S.J., CHUNG H.Y.: Peroxynitrite scavenging activity of herb extracts. Phytother Res 16 (4): 364-367; 2002.
4. HAMMER K.A., CARSON C.F., RILEY T.V.: Anti-Fig. 9 - Physician’s judgment on treatment and Overall conditions of the woman vs pre-treatment in Bacterial vaginosis, Candida, Pregnancy and Puerperium before and after 4 weeks of Thyme extract daily use for inti-mate hygiene.
Fig. 10 - Physician’s judgment on treatment and Overall conditions of the woman vs pre-treatment in Menopause before and after 4 weeks of Chamomile extract daily use for intimate hygiene.
27-31, 2002.
8. MUSSIDA M., ROSA C., INFANTINO M., PIFAROTTI G.: Importance of Salvia officinalis extract in intimate hygiene. 11th
International Congress of Gynecological Endocrinology (ISGE), February 26-29, 2004 - Florence-Italy.
9. RADTKE O.A., FOO L.Y., LU Y., KIDERLEN A.F., KOLODZIEJ H.: Evaluation of sage phenolics for their
antileishma-nial activity and modulatory effects on interleukin-6, interferon and tumour necrosis factor-α-release in RAW 264.7 cells. Z. Naturforsch 58c: 395-400; 2003.
10. SALLER R., BUECHI S., MEYRAT R., SCHMIDHAUSER C.: Combined herbal preparation for topical treatment of herpes labialis. Forsch Komplementarmed K Natur 8: 373-382; 2001. 11. SERKEDJIEVA J.: Inhibition influenza virus reproduction by
com-bined preparations of medicinal plants. Antiviral Res 1994.
12. SUHR K.I., NIELSEN P.V.: Antifungal activity of essential oils
evaluated by two different application techniques against rye bread spoi-lage fungi. J Appl Microbiol 94: 665-674; 2003.
13. TOSI M.T, MANCINI R, STURLA C., MONTUORI M.:
Ruolo degli estratti di Thymus vulgaris e di Salvia officinalis nell’igiene intima. AMCLI 2004 - XXXIII Congresso Nazionale
Associazione Microbiologi Clinici Italiani - Padova 8-11 giu-gno 2004.
14. BRAGA P.C., DAL SASSO M., CULICI M., MUCCI M.:
Thymol: inhibitory activity on Escherichia coli and Staphylococcus aureus adhesion to human vaginal cells. 12thWorld Cong Hum
Reprod, 10-13 March, Venice, Italy, 2005.
15. DIDRY N., DUBREUIL L., PINKAS M.: Activity of thy-mol, carvacrol, cinnamaldehyde and eugenol on oral bacteria. Pharm Acta Helv. 69: 25-28; 1994.
16. DURSUN N., LIMAN N., OZYAZGAN I., GUNES I., SARAYMEN R.: Role of thymus oil in burn wound healing. J Burn Care Rehabil 24 (6): 395-399; 2003
17. FAN M., CHEN J.: Studies on antimicrobial activity of extracts from
thyme. Wei Sheng Wu Xue Bao 41 (4): 499-504; 2001.
18. FRIEDMAN M., HENIKA P.R., MANDRELL R.E.:
Bactericidal activities of plant essential oils and some of their isolated constituents against Campylobacter jejuni, Escherichia coli, Listeria monocytogenes, and Salmonella enterica. J Food Protection 65 (10):
1545-1560; 2002.
19. INOUYE S., UCHIDA K., YAMAGUCHI H.: In-vitro and
in-vivo anti-trichophyton activity of essential oils by vapour contact.
Mycoses 44: 99-107; 2001.
20. KARAPINAR M., AKTUG S.E.: Inhibition of foodborne
patho-gens by thymol, eugenol, menthol and anethole. Int J. Food Microbiol
4: 161-166; 1987.
21. KOKELJ F., PLOZZER C., TORTORA L., BENVENUTI C.: Clinical activity of thymus vulgaris and econazole on tinea pedis
interdigitalis. European Academy of Dermatology and
Venereology, 25-18 October, Barcelona, 2003.
22. LAMBERT R.J.W., SKANDAMIS P.N., COOTE P.J., NYCHAS G.J.E.: A study of the minimum inhibitory concentration
and mode of action of oregano essential oil thymol and carvacrol. J
Applied Microbiol 91: 453-462; 2001.
23. LEE K.G., SHIBAMOTO T.: Determination of antioxidant
potential of volatile extracts isolated from various herbs and spices. J
Agric Food Chem 50: 4947-4952; 2002.
24. MARINO M., BERSANI C., COMI G.: Antimicrobial activity
of the essential oils of thymus vulgaris L. measured using a bioimpedo-metric method. J Food Protection 62 (9): 1017-1023; 1999.
25. TACCONI E., PORTALUPPI P., CAMANA M.G., BENVENUTI C., GUALANDRI V.: Le proprietà antimicrobiche
dell’estratto di timo: confronto dell’attività esercitata su patogeni e su un sim-bionte umano. Riv. Ost. Gin. Prat XVIII (2): 2-5; 2003.
26. TOSI M.T, MANCINI R, STURLA C., MONTUORI M.:
Ruolo degli estratti di Thymus vulgaris e di Salvia officinalis nell’igiene intima. AMCLI 2004 - XXXIII Congresso Nazionale
Associazione Microbiologi Clinici Italiani – Padova 8-11 giu-gno 2004.
27. VARDAR-UNLU G., CANDAN F., SOKMEN A., DAFERERA D., POLISSIOU M., SOKMEN M., et al.:
Antimicrobial and antioxidant activity of the essential oil and methanol extracts of thymus pectinatus fisch. et mey. Var. pectinatus (Lamiaceae). J Agric Food Chem 51: 63-67; 2003.
28. VIOLLON C., CHAUMONT J.P.: Antifungal properties of
essential oils and their main components upon cryptococcus neoformans. Mycopathologia 128 (3): 151-153; 1994.
29. ZAGNI R, DEL BOCA G, MATTACE RASO F.: Effect of
extract of Thymus vulgaris and Salvia officinalis in vulvovaginitis. 11th
International Congress of Gynecological Endocrinology (ISGE), February 26-29, 2004 - Florence - Italy.
30. ZHENG W., WANG S.Y.: Antioxidant activity and phenolic
com-pounds I selected herbs. J Agric Food Chem 49 (11): 5165-5170;
2001.
31. KEDZIA B.: Przeciwdrobnoustrojowe dzialanie ol. chamomillae i
jego skladnikow. Herba polonica, 1: Tom XXXVII, 1991.
